ANZCTR search results

Depression is a common and serious complication after stroke with extensive implications for mental health, functional recovery and health service utilisation (Hackett and Pickles, 2014). Pharmacological therapy has no clear effect on prevention or treatment of post-stroke depression (Hackett et al., 2008), suggesting alternative approaches are required. One novel intervention generating interest is non-invasive brain stimulation (NIBS), with studies reporting some beneficial effects of stimulating hypoactive frontal brain regions; the dorsolateral prefrontal cortex (DLPFC) (Shiozawa et al., 2014). However, few studies have been conducted in people with post-stroke depression so we do not know if this is a viable therapy. We primarily aim to investigate whether NIBS improves post-stroke depression in a pilot RCT

Only a small proportion of available mental health apps have any research backing up claims of efficacy. The present research will use a methodology that will provide timely results using a rigorous scientific process in a manner that can potentially offer valuable information prior to running larger randomised controlled trials, and/or enrich the results of larger randomised controlled trials. This research will also add to the paucity of independent research that currently exists in this area, something that has been called for in the literature. This research is important, because the advent of efficacious mental health apps has the following potential benefits: portability and accessibility (having immediate access to help any time); a convenient way of doing homework activities from face-to-face sessions; ability to set reminders for any number of things, e.g. taking medication; people on waiting lists for face-to-face services may be able to get help via a mobile app; increased anonymity; improved access to treatment for people in rural and remote areas; access difficult to reach groups such as teenagers; and reduce the burden on primary care health services. Research questions/aims/objectives/hypothesis: 1. Do the apps in this study provide clinically significant improvements in symptoms of anxiety and/or depression? 2. What individual characteristics of participants influence the results in this regard? 3. Are there any characteristics of the apps themselves that may influence the results? We will examine a total of five mental health apps for their effectiveness in reducing symptoms of anxiety and/or depression. All apps have published evidence of their effectiveness in peer-reviewed journals, and all five are freely and publicly available in the major app stores for both iOS and Android devices.

This study seeks to show that Remission of T2D may be achieved by following a VLCD combined with lifestyle education over a 1 year period. Participants will undergo a meal replacement diet (VLCD) for 3 months with a gradual reintroduction to healthy eating. This will be done under the care of an Endocrinologist, dietitian and diabetes nurse. It is expected that participants will have an improvement in glycemic control with some achieving diabetes remission, leading to a reduction or cessation in diabetes medications after completion of the 1 year study

The aims of this pilot study are to investigate the feasibility and efficacy of an eHealth program in 20 participants with diabetes with clinically symptomatic diabetic sensory polyneuropathy (DSPN). The e-Health program uses a smartphone app that collects data from a wrist-worn heart rate monitoring device and calculates a weekly Physical Activity Intelligence (PAI) score. PAI is an innovative, scientifically valid and easily understood metric that informs individuals about the quantity and intensity of physical activity needed to obtain or sustain good health. The primary aims of this study were to investigate the feasibility, acceptability and safety of the PAI e-health program in people with DPN. The secondary aims were to explore the clinical impact of the PAI e-Health program on physical activity, sleep and symptoms including the intensity of DPN symptoms and quality of life. It was hypothesised that participants who attended the program would be satisfied with the e-health program and PAI technology, be able to achieve health-enhancing levels of physical activity and not experience major adverse events.

The use of compounded topical pain creams to reduce pain and inflammation has increased dramatically, yet their effectiveness has not been well evaluated. This study compares the efficacy of two topical compound cream in reducing acute postoperative and/or chronic arthritic knee pain. In this double-blind, randomised study we examine two topical creams; Ketoprofen 10% only verses a compound cream (Ketoprofen 10% plus amitriptyline 5%, gabapentin 5%) applied twice a day. Findings of this study will identify which compound combination is more superior in reducing the knee pain in of 2 clinical populations 1) those experiencing postoperative knee pain; and 2) arthritic knee pain.

This clinical trial is assessing the safety and efficacy of a modified virus (ASN-002) to treat low risk basal cell carcinoma skin cancer alone or in combination with a chemotherapeutic agent. Who is it for? You may be eligible join this study if you are aged 18 years or more and have at least one histologically confirmed low risk nodular and/or superficial basal cell carcinoma of 6-20mm in diameter, and are in acceptable general health. Trial details This study is conducted in two parts. Participants in Part A will be administered the modified virus (ASN-002) in combination with a chemotherapeutic agent (at one of 3 different doses). Both agents will be injected directly into the same skin cancer lesion once a week for 3 weeks. Participants in Part B will receive ASN-002 only (without a chemotherapeutic agent) into one or multiple lesions once weekly for 3 weeks. All participants will have the skin cancers surgically removed approximately 5 months after the injections. Participants will be assessed in clinic and by telephone for up to 24 weeks in order to monitor safety and tolerability of treatments. The cancers will also be measured and photographed to see how they respond to treatment. It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone and in combination with a chemotherapeutic agent for BCC.

Hip osteoarthritis is major public health problem with significant personal, social and economic burden. Exercise is central to self-management., but little is known what type of exercise is best. Our primary aim is to evaluate whether people with hip osteoarthritis respond differently to two types of exercise interventions i) lower-limb muscle strengthening and ii) lower limb muscle strengthening with aerobic physical activity. People with hip osteoarthritis will be randomly allocated into one of two different 9-month home exercise programs. Over the first 12 weeks participant will attend 9 in clinic physiotherapist appointments. The physiotherapist will prescribe a home exercise program following the exercise protocol assigned to the participant. Primary outcomes are overall hip pain and physical function measured at 12 weeks. The findings of this study will help determine which of the two exercise program are best for people with hip osteoarthritis and will guide clinicians in providing appropriate evidence-based advice for patients.

Milk Thistle has been used in medical remedies for 2000 years as a therapeutic herbal medicine in the treatment of acute and chronic liver diseases. Some of its effects have been shown to due to an antioxidant and anti-inflammatory effect. There is also evidence that an active constituent within Milk Thistle called Silibinin inhibits an enzyme that works on the bile pigment called bilirubin which allows its excretion from the body. Inhibition of this enzyme would allow bilirubin levels to rise to produce a condition called ‘mild hyperbilirubinemia’. Many clinical studies demonstrate a dramatic reduction in cardiovascular disease (CVD) and atherosclerosis in patients that is directly attributed to elevated bilirubin levels in the blood. This effect is in part due to the powerful anti-oxidant properties of bilirubin. The aim of this study is to see if taking Milk Thistle extract will increase bilirubin levels and over time, may provide protection from heart disease.

This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensor accuracy will be evaluated over a 7 day period as well as infusion site patency and tolerability of the experimental device. Participants will be changed to a study pump for the duration of the study. In addition to utilizing the study device in a free living state, all participants will also undergo two high carbohydrate mixed meal challenges to assess the performance and accuracy of the study device.

The aim of this study is to determine whether regular consumption of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower, kale) results in short-term improvement in measures related to cardiovascular disease risk, including blood pressure, arterial stiffness, glycaemic control, and circulating biomarkers of oxidative stress and inflammation. Twenty-eight participants (50-75 years) with mildly elevated blood pressure (systolic blood pressure 120-160 mmHg) will complete two 2-week interventions in a random order, separated by a 2-week washout period. During each intervention, participants will consume 4 servings/day (300 g) of vegetables as a soup (~500-600 mL/day). The 'active' soup will consist of cruciferous vegetables (broccoli, cabbage, cauliflower, kale) and the ‘control’ soup will consist of other commonly consumed vegetables (potato, sweet potato, carrot, pumpkin). Both soups will be approximately matched for energy, protein, fat, and carbohydrate content. All measurements will be performed at the beginning and end of each intervention period.